Expert Advice Community

Guest

IDE Requirements -Process

  Quote
Guest
Sharon Moore Denise moore Created:   Dec 08, 2020 Last commented:   Dec 08, 2020

IDE Requirements -Process

What is the process to submit an IDE to FDA? Is there an outline/checklist  for this process? Please provide information for clarity and understanding.

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Dec 08, 2020

All information regarding the Investigational Device Exemption (IDE) you can find on the following web page: https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide

If you look at the following chapter, you will find what is the approval process for the IDE:https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Dec 08, 2020

Dec 08, 2020